An Evaluation of Yoga Therapy for Cervical Spondylosis

Sponsor

NMP Medical Research Institute (Other)

Overall Status

Completed

CT.gov ID

NCT04113473

Collaborator

Yog-Kulam (Other)

Enrollment

Location

Arms

8.6

Actual Duration (Months)

7.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Cervical spondylosis is a chronic degenerative condition, commonly affecting >40-year-old adults worldwide. Cervical spondylosis is an important cause of neck pain and low back pain, and seriously affects the physical health, mental health, patients quality of life. Yoga has been most commonly used intervention for pain conditions. But its efficacy in cervical spondylosis has not yet been studied in clinical trials. The primary aim of the present study was to assess the efficacy of yoga chikitsa (therapy) compared with control intervention for neck pain caused by cervical spondylosis.

Condition or Disease	Intervention/Treatment	Phase
Cervical Spondylosis Neck Pain	Other: Yoga Therapy	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

62 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

Effectiveness of Yoga Therapy for Neck Pain Relief in Patients With Cervical Spondylosis

Actual Study Start Date :

Dec 11, 2018

Actual Primary Completion Date :

Jul 12, 2019

Actual Study Completion Date :

Aug 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Yoga Group Experimental group received individualised yoga therapy twice a week for an hour for 12-weeks.	Other: Yoga Therapy An hour of yoga therapy included loosening exercise (sukshma vyayama), yoga postures (asana), yoga breathing (pranayama), relaxation (shavasana) and meditation. Each participant were given handouts to follow home practice sessions everyday for twice a day for at least 15 minutes.
No Intervention: Control Group Control group were given education session and continued on usual care for 12-weeks.

Arm

Intervention/Treatment

Experimental: Yoga Group

Experimental group received individualised yoga therapy twice a week for an hour for 12-weeks.

Other: Yoga Therapy

An hour of yoga therapy included loosening exercise (sukshma vyayama), yoga postures (asana), yoga breathing (pranayama), relaxation (shavasana) and meditation. Each participant were given handouts to follow home practice sessions everyday for twice a day for at least 15 minutes.

No Intervention: Control Group

Control group were given education session and continued on usual care for 12-weeks.

Outcome Measures

Primary Outcome Measures

Neck pain [Change from baseline to 12 weeks]
ain intensity was measured by a 10-cm VAS scale, with 0 = "no Pain" and 10 = "the worst imaginable pain

Secondary Outcome Measures

Disability [Change from baseline to 12 weeks]
Neck disability was measured using neck disability index (NDI) score
Health related Quality of Life [change from baseline to 12 weeks]
Short Form-36 assessed the Quality of life

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Neck pain of CS as per diagnostic criteria of International Classification of Diseases
CS supported by a physical examination, and cervical radiographic examination
History of neck pain longer than 3 months
willing to provide informed consent

Exclusion Criteria:

History of neck trauma, fracture or surgery,
Systematic disease of the neck or spine including bones and joints conditions,
Pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pain Clinic, NMP Medical Research Institute	Jaipur	Rajasthan	India

Sponsors and Collaborators

NMP Medical Research Institute
Yog-Kulam

Investigators

Principal Investigator: Neha Sharma, PhD, Yog-Kulam
Study Director: Shekhar Sharma, NMP Medical Research Institute, India
Study Chair: Jaydeep Joshi, Yog-Kulam

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

NMP Medical Research Institute

ClinicalTrials.gov Identifier:

NCT04113473

Other Study ID Numbers:

NMP/62548

First Posted:

Oct 2, 2019

Last Update Posted:

Oct 2, 2019

Last Verified:

Oct 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Spondylosis

Neck Pain

Study Results

No Results Posted as of Oct 2, 2019